ObesityNCT05936385
Mobile Integrated Care for Childhood Obesity
A study testing Healthy Lifestyle in people with Obesity, run by Nemours Children's Health System at 3 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate a new way of providing healthcare to children with an unhealthy weight. Families who participate will be assigned by chance to one of two groups. One group will see their child's primary care provider to talk about healthy lifestyles for 6 months. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Healthy Lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jul 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Child 4-12 years of age
- Child is a patient of the Nemours Children's Health primary care clinics in Milford, Seaford, and Millsboro
- Child has a BMI ≥ 95% for age and sex
- Child is from a clinic serving rural neighborhoods (RUCA ≥ 4)
Who cannot join
- Caregiver not child's legal guardian
- Caregiver not proficient in English or Spanish
- Caregiver does not have a device and reliable internet
- Child has a genetic syndrome or endocrine disorder that predisposes to obesity
- Child is on a medication that impacts weight
- Child is already enrolled in a weight management program
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Nemours Children's Health, Milford
Milford, Delaware, 19963
Nemours Children's Health, Millsboro
Millsboro, Delaware, 19966
Nemours Children's Health, Seaford
Seaford, Delaware, 19973
About this study
The goal of this clinical trial is to evaluate a new way of providing healthcare to children with an unhealthy weight.
Families who participate will be assigned by chance to one of two groups. One group will see their child's primary care provider to talk about healthy lifestyles for 6 months.
Read more
The other group will be in our Healthy Lifestyle program for 6 months. This will include:
- Check-ins with lifestyle specialists and community health workers,
- A mobile app to help support a healthy lifestyle, and
- Access to community programs and activities.
The main questions the study aims to answer are:
- Do children in the Healthy Lifestyle program have better weight outcomes?
- Do more families in the Healthy Lifestyle program stay in the study?
- Does the Healthy Lifestyle program work better for families from certain communities?
- Conditions
- Obesity
- Being tested
- Healthy Lifestyle, Standard of Care
- Keywords
- Disparities, Stakeholder engagement, Social determinants of health, Healthcare delivery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy LifestyleBehavioural
Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month.
Standard of CareBehavioural
Weight checks and lifestyle counseling with primary care provider every other month.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Lifestyle | Experimental | Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month. Receives: Behavioral: Healthy Lifestyle |
| Standard of Care | Active comparator | Weight checks and lifestyle counseling with primary care provider every other month. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Adiposity
Change in BMI percentile (above the 95th percentile) for age and sex. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms.
Measured: 6 months
Visit Adherence
Lost to follow-up (attrition) from study as documented in the electronic health record.
Measured: 6 months
Secondary outcomes (2)
Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics
Differences in change in BMI percentile (above the 95th percentile) for age and sex between subgroups based on race, ethnicity, and insurance status. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment.
Measured: 6 months
Differences in Visit Adherence Based on Child Sociodemographic Characteristics
Differences in lost to follow-up (attrition) from study as documented in the electronic health record between subgroups based on race, ethnicity, and insurance status. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start26 Jul 2023
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Thao-Ly Phan, Nemours Children's Health System
- Investigators
- Thao-Ly T Phan, MD, MPH, Principal investigator, Nemours Children's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936385
- Sponsor's protocol ID
- 416-Project
- Other IDs
- P20GM144270
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2023
- Last updated
- 24 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Integrated Care for Childhood Obesity
- ClinicalTrials.gov ID
- NCT05936385
- Acronym / sponsor ID
- 416-Project
- Conditions
- Obesity
- Keywords
- Disparities, Stakeholder engagement, Social determinants of health, Healthcare delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Nemours Children's Health SystemUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Posted 24 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate a new way of providing healthcare to children with an unhealthy weight.
Families who participate will be assigned by chance to one of two groups. One group will see their child's primary care provider to talk about healthy lifestyles for 6 months.
The other group will be in our Healthy Lifestyle program for 6 months. This will include:
- Check-ins with lifestyle specialists and community health workers,
- A mobile app to help support a healthy lifestyle, and
- Access to community programs and activities.
The main questions the study aims to answer are:
- Do children in the Healthy Lifestyle program have better weight outcomes?
- Do more families in the Healthy Lifestyle program stay in the study?
- Does the Healthy Lifestyle program work better for families from certain communities?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Lifestyle | Experimental | Behavioral: Healthy LifestyleHealthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month. |
| Standard of Care | Active comparator | Behavioral: Standard of CareWeight checks and lifestyle counseling with primary care provider every other month. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Child 4-12 years of age
- Child is a patient of the Nemours Children's Health primary care clinics in Milford, Seaford, and Millsboro
- Child has a BMI ≥ 95% for age and sex
- Child is from a clinic serving rural neighborhoods (RUCA ≥ 4)
Key exclusion criteria (6 listed)
- Caregiver not child's legal guardian
- Caregiver not proficient in English or Spanish
- Caregiver does not have a device and reliable internet
- Child has a genetic syndrome or endocrine disorder that predisposes to obesity
- Child is on a medication that impacts weight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy LifestyleHealthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month. | Behavioural | Healthy Lifestyle |
| Standard of CareWeight checks and lifestyle counseling with primary care provider every other month. | Behavioural | Standard of Care |
Primary outcome
Change in Child Adiposity
Time frame: 6 months
Change in BMI percentile (above the 95th percentile) for age and sex. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms.
Visit Adherence
Time frame: 6 months
Lost to follow-up (attrition) from study as documented in the electronic health record.
2 secondary outcomes
Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics
Time frame: 6 months
Differences in Visit Adherence Based on Child Sociodemographic Characteristics
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thao-Ly T Phan, MD, MPH principal investigator
Nemours Children's Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Lifestyle in people with Obesity, run by Nemours Children's Health System at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Adiposity (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.